Coding symbology and a method for printing same

ABSTRACT

The present invention includes forming a coding symbology by disposing a plurality of light-reflecting segments separated by spaces on a substrate. The coding symbology represents fixed information and variable information.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to copending U.S. ProvisionalApplication entitled “Coding Symbology and a Method for Printing Same”,having Ser. No. 60/280,073, filed Mar. 30, 2001, which is entirelyencorporated herein by reference.

This application is a continuation of U.S. Utility application Ser. No.10/075,153 filed Feb. 14, 2002, now U.S. Pat. No. 7,108,184 and claimspriority to U.S. Provisional Application entitled “Coding Symbology anda Method for Printing Same”, having Ser. No. 60/280,073 filed Mar. 30,2001, which is entirely incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a coding symbology containing fixedinformation and variable information, as well as a method fortransferring same. The invention is especially suitable for flexible,transparent thermoplastic containers of liquid products that arecommonly used in medical procedures.

BACKGROUND OF THE INVENTION

Various foodstuffs, liquids, and other substances can be sterilelypackaged in pouch-type flexible containers made from webs of flexiblefilm, sheet stock, or like material that is sealed together along theperipheral edges. There are a number of advantages to these pouch-typeflexible containers, including low weight, durability, and low costfabrication.

Various medical solutions are sterilely packaged in pouch-type flexiblecontainers. The medical solutions can be pharmaceutical, flushes,nutrition, irrigating, respiratory therapy agents, dialysis, blood,blood products, plasma derivatives, plasma expanders, blood substitutes,anti-coagulants, blood preservatives, and the like. Such solutions canbe delivered to a patient through an administration tubing set connectedwith the flexible container. Other medical solutions include enterals,anesthesia inhalants, veterinarian, media, and the like. The containermay include one or more access tubes or fittings through which theliquid is pumped to fill initially the container during manufacture ofthe package and to which the administration set and

The use of bar coding to identify the contents of a container iswidespread in the medical industry. For example, bar code identificationsystems allow a hospital to track electronically its inventory ofpharmaceutical products, and the subsequent billing to the patient forthe use thereof. Bar codes are also used in automated agent compoundingsystems to mix properly the correct and proper amounts of medical andtherapeutic agents. More important, bar codes also allow hospitals tomonitor its medications or other therapeutic fluids that are targetedfor infusion into its patients by marking same with fixed informationsuch as product code names or numbers.

Historically, a two-color system was implemented in bar coding systems.That is, a typical bar code consisted of black lines on a whitebackground. When a bar code reader would read the bar code, the blacklines would absorb the reader's laser light while the white spaces wouldreflect the reader's laser light back to the reader where the reflectedinformation was translated into its corresponding analog counterpart.This two-color system naturally led to the development of a two-stepprocess for printing the bar code.

First, the container was passed through a printing machine that applieda reflective (generally white) background field for the bar code. Next,the container was passed through a second printing machine that appliedthe dark, light-absorbing lines of the bar code over the top of thebackground field. One common printing method was the hot-stamping(die-cast) system.

In a hot-stamping system, a metal die is engraved in the desired imageor bar code, heated to a pre-determined temperature, and applied underpressure to the substrate in order to transfer the image or bar codefrom the hot-stamp foil. The foil acts as the pigment (ink) carrier andis fed between the hot-stamp die and the substrate. One problem is thatthe die has sharp edges that oftentimes damage the flexible substratesheretofore mentioned, thus increasing the scrap rate. Still yet anotherproblem is that the hot-stamp die is costly to produce, taking severalhours, or even days, to manufacture. Accordingly, a hot-stamping systemis unsuitable for printing images representative of variable informationsuch as lot numbers, batch numbers, expiration dates or any other datathat changes in a fixed time period, such as by the minute, hour, orday.

Consequently, the hot-stamping system can be used to print feasibly onlyfixed information such as a product's name, manufacturer, and the like.One method of overcoming this deficiency is to print labels and applythem to the product. Naturally, this increases costs and decreasesproduction rates, as well as opens the possibility for the label(s) tofall off of the product.

Several other problems exist with the hot-stamping system as it relatesto the readability of the bar codes on flexible, transparent containerssuch as those commonly used in the medical industry. The first problemwith the readability of images printed by the hot-stamping system isthat the transparent (light-absorbing) nature of the containers in suchsystems requires that a solid (light-reflecting) background block beprinted on the container before the dark (light-absorbing) lines of thebar code can be printed thereon. Not only is there the increased costassociated with two printing passes to achieve the two colors, but it isalso fundamentally difficult to print a solid background block using thehot-stamping method because air pockets commonly form in the ink, whichcause voids in the block, resulting in an unreadable bar code.Additionally, because the background block naturally requires morepigment or ink than the contrasting bars, there is an increased risk forpigment extractives and leachables to exist in the container's solution.

A second problem is that because the hot-stamping system uses variableheat, variable pressure, and a fixed dwell time to transfer images orbar codes onto the substrate, there is a problem of the ink bleeding orgrowing too thick, which causes an unreadable bar code or poor edgedefinition of the bar code symbology. To correct this problem, the dieshave to be redesigned, re-machined, or re-engraved at a reduced size sothat when applied, the correct bar code size is achieved. Alternatively,the size of the bar code symbology, including bar spacing, could beincreased if space limitations on the substrate so allowed. Bothsolutions, however, increase costs and decrease productivity. A thirdproblem is that the inks in a hot-stamping system are designed to adhereto the underlying substrate, and not each other, further contributing toan unreadable bar code and mandating the development of inks that adhereto each other. Fourth, hot-stamping typically yields a bar code with a“D” or “F” American National Standards Institute (ANSI) scale read (with“A” being the highest resolved image). See e.g, American NationalStandard for Information Systems—Bar Code Print Quality Guidelines, byThe American National Standards Institute, © 1990 by InformationTechnology Industry Council, and which is incorporated by reference asthough set forth herein.

At least one attempt has been made to reduce the problems associatedwith a two-color, hot-stamping system, and is found in PCT patentapplication number PCT/US99/05614, bearing International PublicationNumber WO 99/49408, which is incorporated herein by reference as thoughfully set forth herein. The '408 application discloses a containerbearing a negative image bar code generated using the above-describedhot-stamping system (page 8, lines 22–24). The bar code is a negativeimage in that the light-reflecting segments of the underlying substratecorrespond to the background spaces (generally white) of a traditionalbar code, and the light-absorbing segments of the underlying substratecorrespond to the light-absorbing dark segments (generally black) of atraditional bar code.

Even prior thereto, the ability to print a negative bar code image hadbeen known in the art as evidenced in the publication Barcodes and OtherAutomatic Identification Systems, by Robert D. LaMoreaux at page 176, ©1995 by Pira International, which is incorporated herein by reference asthough fully set forth herein. Notwithstanding the advantages of aone-color system, the remaining aforementioned problems with thehot-stamping system still exist, including the inability to print fixedand variable information in a single printing pass.

Unlike the hot-stamping system, the thermal transfer printing systemuses a low level of heat that transfers images (such as a bar code) froma printing head under light contact with the substrate. Because the barcode is not printed under pressure, there is a superior bar codesymbology edge definition. That is, thermal transfer printing generallyyields bar codes with an “A” or “B” ANSI scale read. Furthermore, thepresent inventors found that when an “A” quality code is printed usingthe thermal transfer system, the same code produces a “C” quality readthrough a 10 mil high-density polyethylene overpouch, the overpouchbeing well-known in the medical art.

Another benefit of the thermal transfer printing system is that becausethe print head contains no sharp edges like the hot-stamp die, the printhead does not damage the flexible substrate, thus reducing the scraprate. Another benefit is that the thermal transfer printing system usesless pigment or ink that the hot-stamping system, resulting in a lowerrisk of leachables or extractables in the container's solution. Stillanother benefit is that the thermal transfer printing head yields ahigher degree of flexibility than the hot-stamp die because the imageinformation can be easily changed in a matter of minutes at an inputterminal, as opposed to waiting hours, or even days, for a hot-stamp dieto be redesigned, re-machined, or even re-created. There are a number ofthese thermal transfer systems commercially available from differentmanufacturers such as SmartDate® (MARKEM) and Jaguar J27i4 (NorwoodMarking Systems).

Still yet another benefit of the thermal transfer printing system overthe hot-stamping system is the ability to print smaller bar codes thatwill be accurately read. For example, the thermal transfer printingsystem requires on average approximately one-third to two-thirds of thelength required for the hot-stamping system to print a code of acomparable symbol grade, depending on the substrate. In short, thethermal transfer printing system requires less space and providessuperior bar code edge definition over the hot-stamping system. Theseadvantages allow one to print fixed and variable information, includingthe label copy information, on pharmaceutical and medical agents, oneither side, or both sides, of a container. Conversely, the size andresolution limitations of the hot-stamping method force one to printfixed information on one side of the container and variable informationon the other side. These limitations add the manipulation of turning thecontainer over and running a second printing pass, which in turn,increases costs and decreases productivity. Accordingly, the thermaltransfer printing system affords improved cost efficiency, timeefficiency, and bar code image resolution over the hot-stamping system.Notwithstanding, there still exists the problem of printing in a singlepass a high resolution, one-color bar code that contains both fixedinformation and variable information.

The present invention is provided to solve these and other problems.

SUMMARY OF THE INVENTION

The present invention provides a novel identification system and amethod for employing the system. The identification system can be usedto control inventory, to track a patient's billing, to monitorparticular dosages, to reduce potentially patient safety errors whenused in combination with other safety systems possibly not yet employedand those as described in U.S. Pat. Nos. 6,139,495; 6,032,155;5,845,264; and 5,700,998 which are incorporated by reference as thoughfully set forth herein, and to accomplish innumerable other means andmethods.

The coding symbology of the present invention comprises a substrate anda plurality of light-reflecting segments separated by spaces that aredisposed on the substrate. The spaces on the substrate definelight-absorbing segments. Together, the light-reflecting segments andthe light-absorbing segments define a negative image bar coderepresenting fixed information and variable information.

The present invention further provides that the coding symbology isdetectable using a reader. It is understood that a reader can be anyform of a bar code reader presently known, the details of which form nopart of the present invention. In general, the bar code reader directs aform of energy on the image or bar code and receives all or a portion ofthe energy that is reflected from the image or bar code. Preferably, thereader will then translate the reflected energy into a data form readilyunderstood by humans.

The present invention also provides that the light-reflecting segmentsare indicia that can be detected by a reader, even though the indiciamay or may not be visible to the naked human eye. That is, thelight-reflecting segments may exist at a wavelength outside the visiblelight spectrum. It is known within the art that bar codes could befluorescent, which is outside the visible spectrum and is the subject ofU.S. Pat. No. 5,547,501, which is incorporated by reference as thoughfully set forth herein. In short, the present invention contemplatesboth visible and invisible coding symbologies, or a combination thereof,provided that the reflectivity difference between the light-reflectingsegments disposed on the substrate and the light-absorbing segmentsdefined on the substrate enables the resulting image to be detected by areader. If the indicia are visible to the naked human eye, the indiciacan have a color within the visible light spectrum.

The substrate can be of any chemical composition, preferably comprisinga thermoplastic polymer or a thermoset polymer, and even more preferablywhere the substrate comprises a medical container. In anotherembodiment, two or more coding symbologies are disposed on a substratewherein the combination of the two or more codes represents fixed andvariable information. Two or more codes could also be disposed within acontainer system comprising at least one substrate forming a containerand at least one material. One coding symbology or a plurality ofsymbologies could be disposed anywhere in the container system. Thepresent invention contemplates that the container system comprises asubstrate forming a medical container and a material forming anoverpouch that covers at least a part of the substrate.

The present invention also provides a method for transferring a negativeimage bar code onto a web of material by first providing a web ofmaterial. The next step of the method is to provide a printer capable oftransferring a negative image bar code onto the web in response to asignal representative of the negative image bar code. According to theinvention, the negative image bar code represents fixed information andvariable information. The negative bar code image is then transferred tothe printer via the signal and transferred onto the web of material.Preferably, the printer is a thermal transfer printer. The presentmethod also contemplates that any predetermine number of negative imagebar codes could be transferred in this manner.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the best mode for carrying outthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary, perspective view of a coding symbologyrepresenting fixed information and variable information in a single,collective image transferred onto a substrate.

FIG. 2 is a fragmentary, perspective view of a coding symbologyrepresenting fixed information and variable information in at least two,collective images transferred onto a substrate.

FIG. 3 is a fragmentary view of a container system having a substratewith a coding symbology representing fixed information and variableinformation, and a material positioned over a portion of the codingsymbology.

FIG. 4 illustrates the relative position of the Laser Scanner to thebarcode in the comparative analysis.

FIG. 5 shows an exemplary coding symbology produced by hot-stamp orthermal transfer methods.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

While this invention is susceptible of embodiments in many differentforms, and will herein be described in detail, preferred embodiments ofthe invention are disclosed with the understanding that the presentdisclosure is to be considered as exemplifications of the principles ofthe invention and are not intended to limit the broad aspects of theinvention to the embodiments illustrated.

FIG. 1 illustrates a negative image bar code image representing fixedinformation and variable information that is transferred on a substrate.The bar code is designated generally by reference numeral 20. The barcode 20 includes a plurality of light-reflecting segments 22 that areseparated by spaces 24. The spaces 24 define light-absorbing segments26. The light-reflecting segments 22 and light-absorbing segments 26define the negative image bar code 20 representing fixed information andvariable information. The bar code 20 and the light-reflecting segments26 are disposed on a substrate 30.

The substrate 30 can be any known chemical composition, including athermoplastic or thermoset polymer. Suitable thermoplastic and thermosetpolymers are polyvinylchloride, polyvinyldichloride, polyolefins,polyamides, polycarbonates, polyesters, thermoplastic elastomers,elastomers, polyimides, polyurethanes, ethylene vinyl alcoholcopolymers, ethylene vinyl acetate copolymers, ethylene copolymers,propylene copolymers, acrylic acid copolymers, ethylene substitutedacrylic acid copolymers, α-olefin substituted acrylic acid copolymers,hydrocarbon block polymers, ethylene propylene diene polymers, nylon,mono-layer film structures, and multi-layer film structures such asthose disclosed in U.S. Pat. Nos. 6,168,862; 6,083,587; 5,998,019;5,993,949; 5,935,847; 5,693,387; 5,686,527; 4,299,367; and 3,912,843,which are incorporated by reference as though fully set forth herein.The α-olefin, which preferably contains about 2 to 20 carbons, could beproduced by any method known generally. More particularly, the α-olefinis ethylene or propylene.

Preferably, the substrate 30 is of a chemical composition such that thereflectivity difference between the substrate 30 and thelight-reflecting segments 22 allows the light-reflecting segments 22 toform indicia (not shown) that can be detected by a reader (not shown).In terms of percent reflectance, it is known in the art that a preferredmaximum reflectance for the light-absorbing segments of a codingsymbology is about 25 percent, which also corresponds to the preferredminimum reflectance for the light-reflecting segments. The maximumreflectance of the light-absorbing segments and the minimum reflectanceof the light-reflecting segments need not be achieved simultaneously. Itis preferred that the overall profile reflectance grade of the codingsymbology permits the light-reflecting segments, and more preferably thecoding symbology, to be detected by a reader.

The indicia of the light-reflecting segments 22 may not be visible tothe naked human eye, or preferably, may be visible to the naked humaneye so that the bar code 20 can be easily located and read by a bar codereader (not shown). The indicia of the light-reflecting segments 22 maybe colored white, red, yellow, orange, gold, silver, or any combinationthereof. The preferred color will depend on the reflective index of thechosen substrate and on the wavelength of energy used by the reader. Aspreviously stated, it is understood that any color may be used providedthat the reflectivity difference between the substrate 30 and thelight-reflecting segments 22 allows the light-reflecting segments 22 toform indicia (not shown) that can be detected by a reader (not shown).

According to the invention, fixed information is defined to beinformation that remains unchanged for a first period of time whilevariable information is defined to be information that changes duringthe first period. Examples of fixed information include, but are notlimited to, a product's: name, code number, manufacturer, National DrugCode Number, label copy data required by the Federal Food & DrugAdministration (FDA), or data required by the Health Industry Bar CodeCouncil, now known as the Health Industry Business CommunicationsCouncil (HIBCC), and the like. Examples of variable information include,but are not limited to, a product's: lot number, batch number,expiration date, serial number, production time, price, inventorycontrol data, and concentration.

FIG. 2 shows another contemplated commercial embodiment of the presentinvention and illustrates a fragmentary, perspective view of a codingsymbology representing fixed information and variable information in atleast two, collective images. The coding symbology contains a first barcode 40 representing fixed information and a second bar code 50representing variable information. The first bar code 40 is defined, inpart, by a first plurality of light-reflecting segments 42 separated byspaces 44 and disposed on the substrate 60. The spaces 44 define a firstset of light-absorbing segments 46, which further define the remainderof the first bar code 40.

The second bar code 50 represents variable information. The second barcode 50 is defined, in part, by a second plurality of light-reflectingsegments 52 separated by spaces 54. The spaces 54 define a second set oflight-absorbing segments 56, which further define the remainder of thesecond bar code 50. It is understood that the first plurality oflight-reflecting segments 42 and second plurality of light-reflectingsegments 52 may be of the same chemical composition, although it is notnecessary. In a preferred form of the invention, the first plurality oflight-reflecting segments 42 and the second plurality oflight-reflecting segments 52 are a first indicia (not shown) and asecond indicia (not shown), respectively, that can be detected by areader as heretofore described. The first bar code 40 and the second barcode 60 are disposed on the substrate 60.

As with the indicia related to the light-reflecting segments 22 of theprevious embodiment, the first indicia and the second indicia of thepresent embodiment may not, or preferably may be, visible to the nakedhuman eye. The first indicia (not shown) of the first plurality oflight-reflecting segments 42 or the second indicia (not shown) of thesecond plurality of the light-reflecting segments 52 may be coloredwhite, red, yellow, orange, gold, and silver. The preferred color willdepend on the reflective index of the chosen substrate and on thewavelength of energy used by the reader. As previously stated, it isunderstood that any color may be used provided that the reflectivitydifference between the substrate 60 and the light-reflecting segments42, and between the substrate 60 and the light-reflecting segments 52,allow the light-reflecting segments 42 and the light-reflecting segments52 to form a first indicia (not shown) and a second indicia (not shown),respectively, that can be detected by a reader (not shown).

The present invention contemplates that any predetermined number of barcodes could be disposed on substrate 60 by repeating this procedure.Additionally, it is also understood that substrate 60 could include apredetermined number of symbologies like bar code 20 where fixedinformation and variable information are within the same symbology. Itis also understood that the coding symbologies disclosed herein may beused in conjunction with any current bar code symbologies including, butnot limited to: Code 16K, Code 39, Code 49, Codabar, Code 128, UPC-E,UPC-A, EAN-8, EAN-13, Reduced Space Symbology (RSS), composite symbol,PDF-417, Interleaved 2-of-5 (ITF), as well as two dimensionalsymbologies. It is further understood that either substrate 30 orsubstrate 60, alone or in combination, could be used to further define acontainer whole or in part. It is contemplated that the container couldbe a medical container used to store medical solutions such aspharmaceutical, flushes, nutrition, irrigating, respiratory therapyagents, dialysis, blood, blood products, plasma derivatives, plasmaexpanders, blood substitutes, anti-coagulants, blood preservatives, andthe like. It is also contemplated that the container could be apouch-type flexible container. What is meant by flexible is that themechanical modulus of the container is less than or equal to 40,000 psiwhen measured according to ASTM D-882.

As shown in FIG. 2, the substrate would have an interior surface 64opposed to an exterior surface 62 that would, in turn, define theinterior surface (not shown) and an exterior surface (not shown) of acontainer. The present invention contemplates that the first bar code 40or the second bar code 50 could be disposed on the interior surface 64or the exterior surface 62, or both. Any predetermined number ofsymbologies could also be disposed on the interior surface 64 or theexterior surface 62, or both. It is also contemplated that the first barcode 40, the second bar code 50, or any predetermined number of barcodes (not shown) could be oriented in any manner, including by notlimited to, adjacent, stacked, or overlapping.

FIG. 3 is a fragmentary, perspective view of a container system having asubstrate with a coding symbology representing fixed information andvariable information, and a material positioned over a portion of thecoding symbology. In one embodiment, there is a primary container, whichis referenced by number 80. The primary container 80 has a substrate 82that may be of the same chemical composition as substrate 30 orsubstrate 60 previously described, although it is not necessary. Similarto the previously described embodiments, there is a plurality oflight-reflecting segments 72 separated by spaces 74 and that aredisposed on the substrate 82. The spaces 74 define light-absorbingsegments 76. Together, the light-reflecting segments 72 and thelight-absorbing segments 74 define a bar code 70 representing fixedinformation and variable information. The substrate 82 defines aninterior surface (not shown) and an opposed exterior surface 84 of theprimary container 80.

As part of the container system, there also exists a material 92positioned over a portion of the bar code 70, wherein the bar code isdetectable using a reader (not shown). The bar code 70 can be disposedanywhere on the substrate 82 or even anywhere on the material 92provided that the bar code 70 is detectable using a reader (not shown).In accord with other embodiments disclosed herein, the present inventionalso contemplates any predetermined number of bar codes being disposedon the substrate 82, on the material 92, or both and containing fixedinformation, variable information, or both.

In another embodiment of the container system, the material 92 is a partor the whole of an overpouch 90. The overpouch 90 may cover a portion orall of the primary container 80. Furthermore, the present inventioncontemplates that the primary container 80 may have at least oneperipheral edge 86 that can be heat-sealed, radio-frequency sealed, orotherwise sealed using any known technique the details of which form nopart of the present invention. The material 92 may also be developedinto an overpouch 90 by sealing at least one peripheral edge 94 usingany known technique, the details of which form no part of the presentinvention.

The substrate 82 may be made of any chemical composition provided thatthe reflectivity difference between the light-reflecting segments 72 andthe light-absorbing segments 74 define a bar code 70 that is detectableusing a reader (not shown). Similarly, the material 92 may be of anyknown chemical composition provided that if a bar code 70 were disposedthereon, the reflectivity difference between the light-reflectingsegments 72 and the light-absorbing segments 74 would allow the bar code70 to be detectable using a reader (not shown). Preferably, thesubstrate 82 and the material 92 are of a chemical compositionsufficient to withstand the autoclaving process without adhering to eachother.

It will be understood that the invention may be embodied in otherspecific forms, some of which are set forth below, without departingfrom the spirit or central characteristics thereof. The present examplesand embodiments, therefore, are to be considered in all respects asillustrative and not restrictive, and the invention is not to be limitedto the details given herein.

EXAMPLES

1. Coding Symbology with a Single Bar Code

As stated above, the identification system of the present inventionprovides a coding symbology disposed on a substrate. The inventionfurther provides that a plurality of light-reflecting segments, whichare separated by spaces, is disposed on the substrate. The unmolestedarea of the substrate beneath the light-reflecting segments defineslight-absorbing segments. Together, the light-reflecting segments andthe light-absorbing segments define an image of a bar code. In apreferred form of the invention, the light-reflecting segments and thelight-absorbing segments define a negative image of a bar code.

2. Coding Symbology with Two or More Bar Codes

When a second bar code is used, it is formed in the same general manneras the first bar code. That is, a second plurality of light-reflectingsegments, which are separated by spaces, is disposed on the substrate.The unmolested area of the substrate beneath the light-reflectingsegments defines a second set of light-absorbing segments. Together, thesecond plurality of light-reflecting segments and the second set oflight-absorbing segments define a second bar code. The present inventioncontemplates that any predetermined number of bar codes could begenerated by this procedure. It is understood that when two or more barcodes are employed, the bar codes need not be disposed in physicalcontact with each other, adjacent to each other, or even on the samesubstrate, though such embodiments are contemplated.

3. Container Systems

a. Primary Container with One Bar Code

The present invention further provides that the substrate that forms acontainer may be used as a primary container within a variety ofcontainer systems, which are described herein. In one embodiment, thereis a material positioned over a portion of the substrate, over a barcode located on the substrate, or both. The bar code is disposed on thesubstrate in a manner heretofore described, is detectable using a readeras heretofore described, and represents fixed information and variableinformation as heretofore described. Further, the material in each ofthe container systems may be of the same chemical composition as thesubstrate heretofore described, although it is not necessary to carryout the invention. The primary container, as embodied in each of thecontainer systems of the present invention, may also be of the samechemical composition as the substrate, or the material, or both, asheretofore described, although it is not necessary in order to carry outthe invention. The present invention also provides that the materialfurther comprises a secondary container such as an overpouch and thelike.

It is understood that the primary container has an interior surface andan opposing exterior surface. Any predetermined number of bar codescould be disposed on the primary container's interior surface, theexterior surface, or both, provided that a reader can detect each barcode.

As heretofore described, the light-reflecting segments of thisparticular embodiment also are indicia that can be detected by a reader,and can be either visible or not visible to the naked human eye, or acombination thereof. If the light-reflecting segments are embodied inthe visible spectrum, they can be colored white, red, yellow, orange,gold, and silver, or any color provided that, as heretofore described,the reflectivity difference between the light-reflecting segmentsdisposed on the substrate and the light-absorbing segments defined onthe substrate allows the light-reflecting segments, and preferably theresulting image, to be detected by a reader.

b. Primary Container with Two or More Bar Codes

In one particular embodiment, a primary container has a substrate, andthe substrate has disposed thereon a first bar code. The first bar codeis defined by a first plurality of light-reflecting segments that are onthe substrate, and a first set of light-absorbing segments that aredefined by the spaces in the first plurality. The first bar coderepresents fixed information, variable information, or both.

In the same embodiment, there exists a second bar code on the substrateof the primary container. The second bar code is defined by a secondplurality of light-reflecting segments, and a second set oflight-absorbing segments that are defined by the spaces in the secondplurality. The second bar code represents fixed information, variableinformation, or both. It is understood that the particular location ofthe first bar code and second bar code on the substrate is not critical,provided that both codes remain detectable using a bar code reader. Thepresent invention contemplates that any predetermined number of barcodes could be made using this procedure. As part of the containersystem, there also exists a material, as heretofore described, that ispositioned over a portion of either the first bar code or the second barcode, or both.

c. Primary Container and Material Each with a Bar Code

In yet another embodiment of the present invention, a first bar coderepresenting fixed information or variable information is defined on asubstrate that forms part or all of a primary container. The first barcode is formed in the same general manner heretofore described. Thesubstrate has an interior surface and an exterior surface upon which thefirst bar code could be disposed. This embodiment also provides for amaterial positioned over a portion of the substrate or the first barcode, or both, as heretofore described. The material could furtherdefine a secondary container such as an overpouch, a dustcover, and thelike.

The second bar code represents fixed information or variableinformation, and is defined in the same general manner as describedabove. That is, the second bar code is defined by a second plurality oflight-reflecting segments separated by spaces and disposed thereon, anda second set of light-absorbing segments that are defined by the spacesof the second plurality. The material has a first side adjacent to theprimary container and a second side opposed to the first side upon whichthe second bar code, or any number of bar codes, could be disposed. Thecombination of the first bar code and the second bar code represent bothfixed information and variable information. As with any of the containersystems described herein, two or more bar codes could be disposed on thesubstrate, or on the material, or both.

d. Material with One or with Two or More Bar Codes

The present invention also provides another embodiments for a containersystem wherein the substrate that forms a portion of the primarycontainer has no bar code image disposed on it. Instead, the material asheretofore described has at least one bar code disposed on it. There maybe a single bar code representing both fixed information and variableinformation. In another embodiment, the substrate still contains no barcode, but the material has two or more bar codes disposed thereon. Eachbar code represents fixed information or variable information, or both.Additionally, the material has a first side adjacent to the substrateand a second side opposed thereto upon which any number of bar codescould be disposed. The exact location is not critical, provided that thebar code(s) are detectable by a reader. The bar codes are formed in thesame general manner as heretofore described. If desired, the substratecould also contain any predetermined number of bar codes representingfixed information or variable information, or both.

4. Methods

The present invention also provides a method for transferring a negativeimage bar code onto a web of material. The first step is to provide aweb of material. The web can be of any known chemical compositionprovided that when the negative image bar code is transferred thereon,the reflectivity difference between the negative image bar code and thematerial is sufficient for the image to be detected using a reader. Thenext step of the method is to provide a printer capable of transferringa negative image bar code on the web in response to a signalrepresentative of the negative image bar code having fixed informationand variable information. The signal may be generated by a computer,software execution, a circuit, or any other known methodology, thedetails of which form no part of the present invention. The printer maybe of any sort known generally, preferably a hot-stamp printer, a laserprinter, an ink-jet printer, a flexographic printer, or a thermalprinter; and more preferably a thermal transfer printer.

The next step is transferring the signal to the printer and thentransferring the negative image bar code onto the web of material. Theweb may be any thermoplastic polymer or a thermoset polymer previouslydescribed. As explained above, the exact chemical composition of thematerial is not critical provided that the reflectivity differencebetween the negative image bar code and the material is sufficient forthe negative image bar code to be detected using a reader.

The negative image bar code can be transferred anywhere on the web,including on the web's interior or exterior surface. The presentinvention contemplates transferring the negative image bar code onto aweb of material that contains another bar code, such as a label copy barcode or even another negative image bar code. The web can also form partor all of a container, or all or part of a material such as those usedin the above-described container systems. The present invention alsoprovides for transferring two or more negative image bar codes where thenegative image bar codes represent fixed information, variableinformation, or both, individually or in combination.

Comparative Analysis of Thermal Transfer Versus Hot Stamp Printing

a. Background and Materials

The quality and size of a thermal transfer printed barcode was comparedagainst a hot-stamp printed barcode. For purposes of this analysis, andas will be explained in greater detail below, each barcode wasinvestigated as to whether it would decode upon scanning and produce anaverage ANSI letter grade of “B” or higher. Additionally, the inventorsexamined whether each thermal transfer bar code could be decoded througha 1000 mL overpouch of high density polyethylene having a thicknessdefined below, and which is commercially available from AtoFina Chemical& Oil under the Fina tradename, specifically Grade 7394.

The verification process employed in this comparative analysis involveda precision instrument PSC Quick Check™ 820 Laser/Mouse CompatibleBarcode Verifier (PSC, Inc., Webster, N.Y.) SN: 83987 that is designedto decode bar codes and to evaluate the symbol print quality against apublished ANSI standard, namely ANSI X3.182, which is contained inANSI's Bar Code Print Quality Guideline, 1990 edition. The standard isoutlined below.

Table 1 displays the tracking group identification given to containerstested. Group A included 100 containers commercially available fromAbbott Laboratories (Sterile Water for Injection, USP 2000 mL NDC0074-7118-07) where each container has a hot stamp barcode printed onthe backside of the bag (opposite of label copy). No additionalredesign, sterility treatment or packaging etc. for Group A was requiredor performed on the commercial embodiment. Group B included 300containers commercially available from Baxter Healthcare Corporationknown as PD 185 TC Viaflex® solution bag containers with each containerhaving a thermal transfer barcode printed on it. Table 1 also specifiesthat 60 containers from Group B were designated to and enclosed in anoverpouch of a predetermined thickness.

TABLE 1  8 mil Stock: 1133-9 N = 60 Batch: RT 4-6-01 Box 1 10 mil Stock:1133-8 N = 60 Batch: RT 4-6-01 Box 1

Other equipment used in this analysis includes:

Overpouches: (1000 mL) 100% Fina HDPE Grade—7394

1 Roll 3M 810 Scotch® “Magic™” Tape ID: 34-8506-4916-0

1 Roll Thermal Ribbon ID: TTR-71521

N=300 PVC Membrane Tubes,

-   -   Stock No. 332116,    -   Batch No.: NC Oct. 14, 1999 C 15 Box 1.

Cyclohexanone, Lot No.: 4872 T15641 Exp.: Dec. 6, 2001.

N=300 PD185 TC Viaflex® 1000 mL dual-port Containers:

-   -   Traceability: 3-16-67-134    -   Batch No.: NC 8-31-00C76 Box 4

N=100 Sterile Water for Injection, USP 2000 mL NDC 0074-7118-07

Jaguar J27-I4 Thermal Printer, SN: I4B0066

PSC Laser Scanner Model #: 4100+A3043

-   -   6-mil aperture Mouse Wand (660 nm)    -   10-mil aperture Mouse Wand (660 nm)

N=1 Ruler ID: L12687 Calibration Exp: Apr. 6, 2002

Digital Caliper ID: L8435 Calibration Exp: Mar. 30, 2002

b. Printing of Normalized Thermal Transfer Barcodes and the Scanning ofPre-Sterilized, Hot-Stamped Barcodes

Prior to printing the thermal transfer barcode onto the containers ofGroup B (Baxter), the barcode symbology of Group A (Abbott) was firstidentified, and the encoded data verified against the human readabletext, which was accomplished with the QuickCheck™ 820 Barcode Verifierusing the Laser Scanner.

Table 2 identifies the data encoded, format of the human readable data,and dimensional length/width of the Abbott bar code (N=100).

TABLE 2 Abbott Symbology Encoded Data Format Dimensions Type Data CharsHuman Readable (Visual) X Y Code 128 0100300747118076 16 (01) 0 030074711807 6 72 mm 12 mm (UCC/EAN) 98-4974-R2-6/00

Table 2 illustrates the symbology, data, number of characters, format,and dimensional length/width of the Abbott barcodes. The Abbott barcodeuses a version of Code 128 under the UCC/EAN standard. The datadisplayed under the “Encoded Data” column was retrieved using the LaserScanner of the Quick Check 820™ verifier.

-   -   The dimensional width was measured using a calibrated ruler.    -   The “X” dimension (Length) was measured from the outer side edge        of one quiet zone to the outer side edge of the opposite quiet        zone using a calibrated ruler.    -   The “Y” dimension (Height) was measured from the top edge of the        quiet zone to the bottom edge of the same quiet zone.    -   The “Y” dimension (Height) had no analytical bearing on the        testing procedures for this experiment.

The Abbott barcode was replicated using the Jaguar Printer's imagingsoftware. Once the dimensional layout and identification was created,the image was downloaded into the Jaguar handset. The thermal printerproduced a barcode with the shortest element width (total barcodeelement width=total measured barcode length) of the same symbology,number of encoded data characters, and miscellaneous text identified inthe Abbott barcode. The following steps detail the manner in which theAbbott barcode identification process was conducted:

The QuickCheck™ 820 Verifier was calibrated using the calibrationstandard bar code available inside the user manual (Quick-Check 600Series User Manual, 2^(nd) edition 1994 Part No QCOM600 available fromPSC, Inc.) and then attached to the Laser Scanner (“scanner”). Beforeany scanning was performed, the scanner was held at a distance ofapproximately a 3″ directly above the barcode. As shown in FIG. 4, thescanner was oriented so that the top edge of the scanner is above the“top” side of the barcode and that the bottom edge of the scanner isabove the “human readable data” side of the barcode. Also as shown inFIG. 4, the scanner's aperture surface was oriented to an approximately90° angle above the barcode.

The scanner's trigger was then depressed and held to establish thecorrect scanning position. No data was recorded on this scan. The laserbeam emitted from the scanner's aperture should cross the entire widthof the barcode, as is shown in FIG. 5. Without changing the angle ordistance as specified above, the laser beam was moved to approximatelythe middle of the barcode, also shown in FIG. 5, by moving the scannerin a lateral or vertical direction. The scanner's trigger was released,and the scanner's position was held such that the above-describedscanning position parameters were not changed.

The scanner's trigger was again depressed and held in order to decodeand identify the symbology and encoded data of the Group A barcode. Theresults of the scan were recorded, and the above steps were repeated toscan the remaining barcode samples of Group A. The trigger was depressedonly when the scanner was used to scan a barcode. If an element of thescanning test environment was changed (e.g., lighting), the scanner wasrecalibrated as per above.

Table 3 shows the replication Abbott's (Group A) barcode identificationonto Baxter's (Group B) Viaflex® containers.

The following barcode element width dimensions of N=150 barcodesproduced an equivalent ANSI grade to that of the Abbott barcode. (SeeTable 8)

-   -   X dimension: 22 mm Y dimension: 10 mm

The following barcode element width dimensions of N=150 produced abetter ANSI grade than that of the Abbott barcode. (See Table 8)

-   -   X dimension: 52 mm Y dimension: 10 mm

One barcode was printed on 300 Viaflex® containers and placed inside aplastic bag. The barcodes were printed at random zones or regions of thecontainers.

TABLE 3 Dimensions Symbology Encoded Data Format X Y Type Data CharsHuman Readable (Visual) (N = 150) (N = 150) Code 128 0100300747118076 16(01) 0 030074 711807 6 22 mm 10 mm (UCC/EAN) 98-4974-R2-6/00 52 mm 10 mm

c. Shadow Test

The “shadow” test is a visual inspection test implemented in the barcodeverification process in order to measure the integrity of the label tothe substrate adhesion strength. The test employed Scotch® Magic™ Tape810, which is available commercially from 3M and identified above,whereby the tape produces a shadow of that barcode to which it isapplied. This shadow is the result of the printer's ribbon labeladhering to the tape once it is applied and removed from the barcode.The quantitative amount of “shadow” that is observed on the tape is thenused to assess the integrity of the barcode surface that will surviveabrasive contact or resist melting from extreme temperature conditions.An acceptable tape test result yielded less than approximately 50% ofthe ribbon label is transferred onto the tape. This test also helpedvisually assess any degradation of the barcode quality. The test wasperformed immediately following the print production process and wasdone only for the 300 Group B samples. Table 4 outlines the results:

TABLE 4 Baxter Sterilization Sample Print Size: Phase: Size: 0–50%:51–100%: 22 mm × 10 mm Pre 150 150 0 52 mm × 10 mm Pre 150 150 0

The scotch tape was applied to the barcode immediately following theprint. A small trace (0–50%) of the foil was visible on the strip oftape for all prints. The scotch tape test result yielded less than 50%label transfer on the scotch tape, which qualified it as an acceptableprint. There were no visible peel streaks created in any of the barcodesafter the scotch tape was removed from it. Table 4 reflects data resultsgenerated for both Group B barcodes (1) 52 mm×10 mm and (2) 22 mm×10 mm.A sample size of 150 each was taken from each group.

d. Barcode Verification Scanning: ANSI Grade Report (Pre-Sterilization)

The ANSI Grade Report is an individual scan profile measurement reportof the number of scans used to get a final ANSI Symbol Grade. Thisreport uses the Scan Profile methodology found in ANSI's Bar Code PrintQuality Guideline, which is identified above. The following steps werefollowed for the Viaflex® (Group B) containers. There were no resultsreported for the Abbott (Group A) barcodes because the Abbott containerpre-sterilization stage was not applicable to this protocol.

First, a 6-mil aperture mouse wand was attached to the Scanner. Second,the Quick Check 820 scanner was calibrated (as set forth earlier) priorto scanning the barcode for identification. The Quick Check Verifier wasthen configured to achieve 10 scans per barcode for extended accuracy.Each individual scan of the 10 averaged by the Scanner was recordedduring scanning. The Scanner then reported each scan grade as an alphacharacter. Each barcode on the 300 Group B containers was scanned byrolling the mouse wand over and across the middle of the barcode. Table5 details the results.

ANSI Grade (Pre-Sterilization)—Results:

TABLE 5 Baxter (Group B) - 6 mil Mouse Wand Sterili- Print zation SampleScan Average Dimensions Method: Phase: Size: Pass: Grade: X Y ThermalPre- 150 10 C 22 mm 10 mm Transfer Thermal Pre- 150 10 B 52 mm 10 mmTransfer

Table 5 indicates that the total average ANSI grade produced throughthermal transfer print yielded a “C” out of a sample size of 150 (22mm×10 mm barcodes) and a grade of “B” out of a sample size of 150 (52mm×10 mm barcodes). The sum or total average is the average of eachindividual sample scan average after a scan pass of 10. A 6-mil aperturemouse wand was used to test the grade for the thermal printed barcodes.These samples were tested after printing and prior to fill and pouching.

e. Filling

Table 6 shows the fill and air volume used for the Viaflex® (Group B)containers:

TABLE 6 Container Size Solution Volume (mL) Air Volume Range (cc) 1000mL 1050 mL ± 20 mL 55 cc ± 20 cc

All 300 containers were filled using the specifications listed above inTable 1.

f. Overpouch Assembly and Sterilization Cycles

All 300 Group B containers were transferred to the Vertrod Sealer. Astock roll of 100% HDPE film was cut to the lengths of 13½″×6½″ (Referto Table 1 for thickness of individual stock rolls). The film was thensealed manually using the Vertrod sealer. No defects were observed inthe overpouch material. The containers were loaded inside the overpouchand then sealed. The samples were loaded on the sterilization trays withthe barcode print facing up, whereby the barcode was not in directcontact with the tray. A sterilization cycle was then performedaccording to Specification 14-04-01-119 Cycle No. 04-026 at the maximumtime and temperature conditions (i.e, 56.0 minutes at 252° F.).

g. Barcode Verification Scanning: Decode on Scan (Post-Sterilization)

TABLE 7 Samples Read on Scan Sterilization GROUP N # Pass Fail Pre PostBaxter 300 300 0 N/A 300 Abbott 100 100 0 N/A 300

Table 7 shows that all barcodes were able to be decoded upon scanning.All 300 barcodes on the Viaflex® (Group B) containers and all 100barcodes on the (Group A) Abbott containers were decoded through theirrespective overpouches with the Laser Scanner using scanning proceduresdetailed above. A maximum of 10 scan attempts were performed. The numberof scans actually required to decode each individual units was notrecorded. Only an observational note would be recorded for units failingto decode, of which there were none.

In some cases, water droplets were visible inside in the Baxter (GroupB) overpouch as a result of recent sterilization. The overpouch was thenpressed against the primary container film surface to disperse or removethe water droplets. Human hands were used to smooth away wrinkles thatwere present in the overpouch. The Abbott overpouches were observed tobe completely dry. No overpouches needed to be removed for any barcodeto be decoded.

h. Barcode Verification Scanning: ANSI Grade Report (Post-Sterilization)

For each of the 400 samples in Groups A and B, the respective overpouchwas removed, the port tubes were cut off using scissors, and the sampleswere completely drained of all fluid. The scanning procedures detailedabove were then employed for scanning each barcode and generating anANSI grade report. The 300 Viaflex® samples were scanned using the 6-milaperture mouse wand. The 100 Abbott samples could not be scanned usingthe 6-mil aperture or 10-mil aperture mouse wand. Instead, the LaserScanner was used. One inherent difference between the mouse wand andLaser Scanner is that the mouse wand provides a reflectance grade wherethe Laser Scanner does not. This information may be used as asupplemental analytical tool guide to assess the quality of the barcodeprint in a pre-production print quality control verification process.

Next, a 15 square inch piece from each overpouch used to pouch the 300Viaflex® samples was cut and pressed firmly over the barcode forscanning the barcode through the cut overpouch section. Human fingerswere used to smooth out any wrinkles that were present The same scanningprocedures detailed above were used to scan the barcode through theoverpouch and generate an ANSI grade report. All scans through anoverpouch were achieved using the 6-mil aperture mouse wand. This sameprocedure was repeated for the 100 Abbott barcodes except that the LaserScanner was used instead of the 6-mil wand. Further, the Group Bbarcodes were rescanned using the Laser Scanner to validate that themouse wand and Laser Scanner could achieve the same end results. Thefollowing tables and graphs illustrate the results.

TABLE 8 ANSI Grade (Post-Sterilization); Out of Pouch - Results:Sterili- Aver- Dimen- zation Sample Scan age sions Group: Phase: Size:Pass: Grade: X Y N = Baxter Post 150 10 C 22 mm 10 mm 150 Baxter Post150 10 B 52 mm 10 mm 150 Abbott Post 100 10 C 72 mm 12 mm 100

Table 8 indicates that the total average ANSI grade produced throughthermal transfer print and hot stamp. The sum or total average grade isthe average of each individual sample average after a 10 scan passes.The above tables also reflect the average ANSI Grade of the barcodestested out of their respective pouches. These samples were tested afterprinting and after filling and pouching.

Thermal Transfer Barcodes (Group B):

-   -   The thermal transfer print yielded an average ANSI grade “C” out        of a sample size of 150 for the 22 mm×10 mm Baxter barcode and        an average ANSI grade of “B” for the 52 mm×10 mm Baxter barcode.        A 6-mil aperture mouse wand was used to test the grade for the        thermal printed barcodes. In addition, a Laser Scanner was used        and yielded the same results.

Hot Stamp (Group A):

-   -   The hot stamp print yielded an average ANSI grade “C” out of a        sample size of 100 in both table results. A Laser Scanner was        used to scan the hot stamp barcodes. A scan using a 6-mil        aperture or 10-mil aperture mouse wand aperture was not        achievable when testing the hot stamp barcode.

TABLE 9 ANSI Grade (Post-Sterilization); In Pouch - Results: Pouch PrintSample Scan Thickness Average Method: Sterilization: Size: Pass: (mils):Grade: Baxter - 22 mm × 10 mm Barcode (Laser Scanner) Thermal Post 21 102 C Thermal Post 21 10 4 C Thermal Post 21 10 6 C Thermal Post 21 10 8 CThermal Post 21 10 10 C Baxter - 22 mm × 10 mm Barcode (Mouse Wand)Thermal Post 21 10 2 C Thermal Post 21 10 4 C Thermal Post 21 10 6 CThermal Post 21 10 8 C Thermal Post 21 10 10 C

TABLE 10 Pouch Print Sample Scan Thickness Average Method:Sterilization: Size: Pass: (mils): Grade: Baxter - 52 mm × 10 mm Barcode(Laser Scanner) Thermal Post 21 10 2 B Thermal Post 21 10 4 B ThermalPost 21 10 6 B Thermal Post 21 10 8 B Thermal Post 21 10 10 B Baxter -52 mm × 10 mm Barcode (Mouse Wand) Thermal Post 21 10 2 B Thermal Post21 10 4 B Thermal Post 21 10 6 B Thermal Post 21 10 8 B Thermal Post 2110 10 B

TABLE 11 Abbott - 72 mm × 12 mm Barcode (Laser Scanner) Pouch PrintSample Scan Thickness Average Method: Sterilization: Size: Pass: (mils):Grade: Hot Stamp Post 42 10 4.5 C

Table 9 indicates that the total average ANSI grade of “C” was yieldedfor 42 (21 Laser Scanner+21 Mouse Wand) 22 mm×10 mm Baxter barcodesamples. Table 10 indicates that the total average ANSI grade of “B” wasyielded for 42 (21 Laser Scanner+21 Mouse Wand) 52 mm×10 mm Baxterbarcode samples. Table 11 also reflects the average ANSI Grade of the 42(Laser Scanner) hot stamp (Abbott) barcodes tested through theirrespective pouches yielded a “C”. The sum or total average is theaverage of each individual sample average after 10 scan passes. A 6-milaperture mouse wand and a Laser Scanner were used to test the grade forthe thermal (Baxter) barcodes. Viaflex® sample numbers 130–150 of eachBaxter barcode dimension size were used to test the print qualitythrough the various overpouches thickness. These samples were testedafter printing and after fill and pouching.

The above show that the thermal transfer print process was able toreduce the Abbott barcode image size (width) by approximately 69% andproduce an equal ANSI Grade Average of “C” both out of pouch and inpouch. In the second part of this experiment, the thermal transfer printprocess was able to reduce the Abbott barcode image size (width) by 28%and produce an average grade of “B” both out of pouch and in pouch,whereby the Abbott barcode only reported an ANSI Grade Average read of“C” (out of pouch). The thermal transfer print process allowed forflexibility of desired barcode image print dimensions through thecontrol of software. The barcode image quality was verified under theprocess of Barcode Print Verification. The verification process requiredthat the Group A and Group B barcodes could be scanned and barcodes,illustrates that the image quality of the barcodes produced by thermaltransfer requires a lesser need for reprinting bad barcodes based uponthe higher quality of print that it produces.

It will be understood that the invention may be embodied in otherspecific forms without departing from the spirit or centralcharacteristics thereof. The present examples and embodiments,therefore, are to be considered in all respects as illustrative and notrestrictive, and the invention is not to be limited to the details givenherein.

1. A container system comprising: a flexible container comprising atransparent plastic film; a plurality of light-reflecting segmentsdisposed on the flexible container film, wherein the flexible containerfilm defines spaces that separate the plurality of light-reflectingsegments, wherein the film that defines the spaces also itself defineslight-absorbing segments, wherein the light-reflecting segments and thelight-absorbing segment define a negative image bar code representingvariable information, wherein the variable information comprises atleast one selected from the group consisting of: lot number, batchnumber, expiration date, serial number, production time, price, andconcentration; and a material positioned over a portion of the negativeimage bar code, wherein the portion of the bar code has an A or B scangrade when decoded through the material and in accordance withANSIX3.182.
 2. The container of claim 1 wherein the light-reflectingsegments are indicia having a color selected from the group consistingof white, red, yellow, orange, gold, and silver.
 3. The medicalcontainer of claim 2 wherein the negative image bar code comprises asymbology selected from the group consisting of: Code 16K, Code 39, Code49, Codabar, Code 128, UPC-E, UPC-A, EAN-8, EAN-13, Reduced SpaceSymbology, composite symbol, PDF-417, and Interleaved 2-of-5.
 4. Themedical container of claim 2 wherein the negative image bar code is atwo-dimensional symbology.
 5. The medical container of claim 1 whereinthe medical container is flexible.
 6. The container of claim 1 whereinthe negative image bar code has a length less than 72 millimeters. 7.The container of claim 1 wherein the negative image bar code has alength less than or equal to 52 millimeters.
 8. The container of claim 1wherein the negative image bar code has a length less than or equal to22 millimeters.
 9. The container of claim 1 further comprising a secondplurality of light-reflecting segments disposed on the film, wherein thefilm defines spaces that separate the second plurality oflight-reflecting segments, wherein the film defining the spaces alsoitself defines a second set of light-absorbing segments, wherein thesecond plurality and the second set define a second negative image barcode, wherein the second negative image bar code can be detected by areader, and wherein the second negative image bar code represents fixedinformation.
 10. The container of claim 9 wherein each negative imagebar code is characterized in having an A or B scan grade when decoded inaccordance with ANSIX3.182 through an overpouch comprising polyethylene,wherein the overpouch has a thickness of at least 2 mils.
 11. Thecontainer of claim 10 wherein each negative image bar code has a lengthless than 72 millimeters.
 12. The container of claim 10 wherein eachnegative image bar code has a length less than or equal to 52millimeters.